lung cancer
Conditions
Interventions
experimental group :apatinib+chemotherapeutics
control group :chemotherapeutics I
Sponsors
Tangdu Hospital of Fourth Medical University of Chinese PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Preoperative pathologically diagnosed stage IIA-IIIA, non-small cell lung cancer patients undergoing adjuvant chemotherapy after R0 resection; clinical stage I (T1-2N0M0) confirmed by pathology before surgery requires assistance after R0 resection Chemotherapy for patients with small cell lung cancer; 3. The ECOG systemic state (the performance status, PS) 0 ~ 1 minute; 4. The main organs function is good, the related inspection indexes meet the following requirements: 1) blood routine inspection: 100 g/L or higher hemoglobin without blood transfusion (14 days); the neutrophil count acuity 1.5 x 10^9/L; the platelet count 100 x 10^9/L or higher; 2) biochemical indeces: total bilirubin acuities were 1.5 x ULN (upper limit of normal); the ALP, ALT and AST 2.5 x ULN or less; the endogenous creatinine clearance or 50 ml/min (Cockcroft - Gault formula). 5. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum), and the results were negative, and willing to during the trial and 8 weeks after the last gives the experimental drug USES the appropriate method of contraception.For men, should be sterilization surgery, or agreed to during the trial and 8 weeks after the last give experimental drug use of appropriate methods of contraception; Subjects were willing to join in this study, signed informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. People with high blood pressure and antihypertensive drug therapy can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. The coagulant function abnormality (INR > 1.5, APTT > 1.5 ULN) with bleeding tendency, or move/vein thrombosis incidents happened in 12 months; 5. Has a history of psychiatric drugs abuse and can't quit or patients with mental disorders; 6. According to the researcher's judgment, there are other serious to endanger the safety of patients or patients with disease to do the research; The researchers think that the person doesn't fit into.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years DFSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years DFSR;OS;QoL;drug safety;SAE; | — |
Countries
China
Contacts
Public ContactJiang Tao
Outcome results
None listed